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Completed

NCT Number: NCT07568652

Clinical Trial to Evaluate the Pharmacokinetics and Safety Between the Single Administration of HL1113 and the Concomitant Administration of HL1113R1 and HL1113R2 for Healthy Subjects in Fasting State

This clinical trial is a randomized, open-label, single oral dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the single administration of HL1113 and the concomitant administration of HL1113R1 and HL1113R2 for healthy subjects in fasting state

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Key information

Conditions

Hypertension Cardiovascular Diseases Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Central Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects aged ≥19 years and <65 years at the time of screening
  • Subjects with a body mass index (BMI) of 18.0 to 30.0 kg/m² at screening(BMI calculated as: weight [kg] / height [m]²)
  • etc.

Exclusion criteria

  • Subjects who have taken medications known to markedly induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to study initiation (first dose), or who have taken medications that may affect the outcome of the study within 10 days prior to study initiation (first dose). However, participation may be allowed if, based on pharmacokinetic/pharmacodynamic characteristics (e.g., drug interactions, half-life of concomitant medications), the investigator determines that such medications will not affect the study
  • Subjects who have participated in a bioequivalence study or any other clinical trial and received an investigational product within 6 months prior to study initiation (first dose)
  • etc.

Treatment and study plan

Test group 1

Drug
  • Period 1 : HL1113R1 + HL1113R2, once daily
  • Period 2 : HL1113, once daily

Test group 2

Drug
  • Period 1 : HL1113, once daily
  • Period 2 : HL1113R1 + HL1113R2, once daily

Primary outcomes

  1. Cmax

    Time frame: 48 hours after administration

Secondary outcomes

  1. AUC∞

    Time frame: 48 hours after administration

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Open-label, Single Oral Dose, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Single Administration of HL1113 and the Concomitant Administration of HL1113R1 and HL1113R2 for Healthy Subjects in Fasting State

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 6, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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